Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Phase 3

Completed

• Conditions: Type II Diabetes Mellitus; Dyslipidemia
• Interventions: Drug: Pitavastatin; Drug: Atorvastatin

• Registration Number: NCT00309751
• Lead Sponsor: Kowa Research Europe

Brief Summary

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Results First Submitted: 2009-08-26
• Results First Submitted QC: 2009-12-11
• Results First Posted: 2010-01-18
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-17
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

• Males and females (ages 18-75 years)
• Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
• Must have been following a restrictive diet
• Diagnosis of combined dyslipidemia

Exclusion Criteria

• Homozygous familial hypercholesterolemia
• Conditions which may cause secondary dyslipidemia
• Uncontrolled diabetes mellitus
• Abnormal pancreatic, liver, or renal function
• Abnormal serum creatine kinase (CK) above the pre-specified level
• Significant heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4 mg QD	Pitavastatin	Pitavastatin 4 mg once daily
Atorvastatin 20 mg QD	Atorvastatin	Atorvastatin 20 mg once daily

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)	12 weeks	Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Name	Time	Method
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target	12 weeks	Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks

Trial Locations

Locations (35)

CCBR Aalborg; 🇩🇰 Aalborg, Denmark

CCBR A/S; 🇩🇰 Ballerup, Denmark

CCBR Vejle; 🇩🇰 Vejle, Denmark

Gemeinschaftspraxis am Bahnhof; 🇩🇪 Berlin-Spandau, Germany

Pharmakologisches Studienzentum Chemnitz; 🇩🇪 Chemnitz, Germany

Internistische Diabetische Schwerpunktpraxis Dr.; 🇩🇪 Frankfurt Am Main, Germany

Internistische Gemeinschaftspraxis; 🇩🇪 Mainz, Germany

Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler; 🇩🇪 Messkirch, Germany

Bhagwan Mahaveer Jain Heart Centre; 🇮🇳 Bangalore, India

Sri Ramachandra Medical College Hospital; 🇮🇳 Chennai, India

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